The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials

Kristian Thorlund; Davey Smith; Christopher Linsell; Nicholas White; Christopher Butler; David Boulware; Judith Currier; Ofir Harari; Edouard Lhomme; Nathalie Strub-Wourgaft; Stacey Adam; Edward Mills

doi:10.1038/s43856-023-00281-1

The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials

Commun Med (Lond). 2023 Apr 17;3(1):53. doi: 10.1038/s43856-023-00281-1.

Authors

Affiliations

¹ McMaster University, Hamilton, Canada.
² School of Health Sciences, University of California San Diego, San Diego, CA, USA.
³ Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program, Vanderbilt University, Nashville, TN, USA.
⁴ Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.
⁵ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
⁶ University of Minnesota Medical School, Minneapolis, MN, USA.
⁷ UCLA Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
⁸ Cytel, Vancouver, Canada.
⁹ Hospital Center University De Bordeaux, Bordeaux, France.
¹⁰ Drugs for Neglected Diseases Initiative, Geneva, Switzerland.
¹¹ Foundation for the National Institutes of Health, North Bethesda, MD, USA.
¹² McMaster University, Hamilton, Canada. millsej@mcmaster.ca.

Abstract

Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible.

Publication types

Review

Grants and funding

MC_PC_19079/MRC_/Medical Research Council/United Kingdom